Oxurion NV announced that it has received Institutional Review Board (IRB) approval to initiate a Phase 2 clinical study of THR-687 in patients with Diabetic Macular Edema (study name “INTEGRAL”). Together with its earlier submission to the U.S. Food and Drug Administration (FDA) of the final protocol to the Investigational New Drug (IND) Application, this is an important step forward for the Phase 2 INTEGRAL study. Today’s announcement follows the positive data reported from a Phase 1, open-label, multi-center (US), single dose escalation study (n=12) evaluating the safety of a single intravitreal injection of 3 increasing doses (0.4 mg, 1.0 mg, 2.5 mg) of THR-687 for the treatment of DME. A single injection of THR-687 was reported safe and well-tolerated, showing a very encouraging efficacy signal. Across all doses, a rapid onset of action in mean BCVA was observed from Day 1 with an increase of 3.1 letters, which further improved to 9.2 letters at Month 1. This activity was maintained with a mean BCVA improvement of 8.3 letters at Month 3 following a single injection of THR-687. A clear dose response was seen with the positive effect on BCVA and Central Subfield Thickness (CST) with the dose of THR-687. For this dose, a mean BCVA Improvement of 11 letters was noted at Day 14, with a peak improvement of 12.5 letters at Month 3. Similarly, a peak mean CST decrease of 106 µm was observed at Day 14 with the dose of THR-687. Beyond DME, THR-687 also has development possibilities in additional vascular retinal disorders including for wet Age-related Macular Degeneration (wet AMD) and retinal vein occlusion (RVO), thereby potentially allowing the Company to tap into a broader therapeutic market with a current combined estimated annual value of $12+ billion.